Inter-Device Reliability of the NPi-300 Pupillometer

Completed

• Conditions: Critical Illness; Neuropathy
• Interventions: Device: NPi-200 and NPi-300 pupillometers

• Registration Number: NCT04993833
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary

The purpose of this study is to explore the inter-device reliability between the NPi-200 and NPi-300.

Detailed Description

Paired assessments will be made on patients who are consented; and on healthy controls who have verbally assented to participate. We plan to enroll 20 patients and 50 healthy controls. Assessments will be made at the convenience of the patient and healthy controls. Each assessment will include bilateral PLR reading within a 5 minute interval. The first assessment will be completed with the NPi-200 and the second assessment will use the NPi-300. The data will be entered into a CRF.

If there is a significant difference between readings from the NPi-200 and the NPi-300, we will repeat the bilateral assessment in the following hour and the regularly scheduled time.

Study Timeline

• Study First Submitted: 2021-07-13
• Study First Submitted QC: 2021-07-28
• Study First Posted: 2021-08-06
• Study Start: 2021-08-25
• Primary Completion: 2022-08-31
• Study Completion: 2022-08-31
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-27
• Last Update Posted: 2022-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy Control	NPi-200 and NPi-300 pupillometers	Staff/Faculty who interact with patients at the enrolling site.
Patients	NPi-200 and NPi-300 pupillometers	Patients with risk of cerebral edema.

Primary Outcome Measures

Name	Time	Method
Pupil's reaction to light as measured by Neurological Pupil Index (NPI)	1 year	Pupil's reaction to light as measured by Neurological Pupil Index (NPI) algorithm using pupillometer device that grades the pupil's reaction to light on a scale between 0 and 5. The Inter-device reliability is assessed using Cohen's Kappa method: values ≤ 0 as indicating no agreement.

Trial Locations

Locations (1)

Clements University Hospital; 🇺🇸 Dallas, Texas, United States